A. Menarini Diagnostics GlucoMen areo 2K User manual

1
Thank you for choosing the GlucoMen® areo 2K meter.
We have designed this compact blood glucose and β-ketone meter for
faster and easier testing of your blood glucose and β-ketone we hope it
will be of great help in the management of your diabetes. This manual
explains how to use your new meter. Before testing, carefully read through
this manual and the package inserts that come with it: GlucoMen® areo
Sensor, GlucoMen® areo β-Ketone Sensor, GlucoMen® areo Control, and
GlucoMen® areo Ket Control. Pay particular attention to listed warnings
and cautions. Please keep this manual at hand for future reference. If you
have any questions, please contact A. Menarini Diagnostics for assistance
(references at the end of this manual).
1. Intended use
Your GlucoMen® areo 2K meter, GlucoMen® areo Sensor, and GlucoMen®
areo β-Ketone Sensor are in vitro diagnostic medical devices to
quantitatively measure glucose and β-ketone levels in fresh capillary whole
blood. They are intended for self testing to monitor and control blood
glucose and β-ketone levels by people with diabetes mellitus; they can
also be used in a clinical setting by healthcare professionals. They are not
intended for diagnosis or screening of diabetes and DKA or for neonatal
use. Do not alter your treatment on the basis of test results of this meter
without previously consulting your doctor or healthcare professional.
Blood Glucose and ß-Ketone
Self-Monitoring System
2. System overview
2.1 Meter
FRONT
TEST STRIP PORT
UP/DOWN ( /)
BUTTONS
ENTER ( ) BUTTON
TEST STRIP PORT
Test strip should be inserted here.
ENTER ( ) BUTTON
Press and hold for 2 seconds to access meter memory (§6.1) or longer
(4 seconds) to enter setup mode while not testing (§7).
UP/DOWN ( / ) BUTTONS
Press or to scroll through different options and/or values.
BACK
BATTERY HOLDER
NFC ANTENNA
DATA TRANSFER PORT
RELEASE BUTTON
RELEASE BUTTON
Press this button to remove used test strip.
BATTERY HOLDER
Houses two CR2032 3V lithium coin cell batteries.
DATA TRANSFER PORT
Connection port for PC data cable and Bluetooth device from A. Menarini
Diagnostics.
METER SCREEN
CLOCK/ALARM ICON HYPO/HYPER ICONS
DROP ICON
MAIN DISPLAY AREA
UNIT OF MEASUREMENT
TIME
AVERAGE
DATEMARKERS ICONS
MEMORY ICON
CTL ICON
GLUCOSE ICON
KETONE ICON
WRONG TEMPERATURE
ICON
NFC ICON
LOW BATTERY ICON
MEMORY ICON: indicates that you are using the memory
(§6).
CLOCK/ALARM ICON: “clock” appears while setting the time
(§7.1); “alarm” appears while setting the
acoustic reminder(s), and will be displayed
if any alarm is on (§7.2).
HYPO/HYPER ICONS: appear while setting the hypoglycaemic
and hyperglycaemic thresholds and if
your test results are below or above these
values (§7.4).
DROP ICON: blinks to indicate that the meter is ready
for blood or control solution testing (§4.2,
4.3).
MAIN DISPLAY AREA: displays test results, stored test values,
result averages and messages.
UNIT OF MEASUREMENT: shows the unit of measurement of your
blood glucose and β-ketone meter
(mg/dL or mmol/L for glucose, not
changeable; mmol/L only for β-ketone).
USER MANUAL
MASTER

2
TIME: shows time (HH:MM, 12H AM/PM or 24H
format).
AVERAGE: shows the period related to the displayed
average (1, 7, 14, 30, 60 or 90 days – §6.2).
DATE: shows the date (DD-MM format).
MARKERS ICONS: displayed while marking a test result (§4.4)
or reviewing a marked result.
Before meal marker.
After meal marker.
Exercise marker.
Check marker.
GLUCOSE ICON: appears when the value shown in the Main
Display Area refers to glucose test results.
KETONE ICON: appears when the value shown in the
Main Display Area refers to β-ketone test
results, while setting the β-ketone test alert
threshold or, if blinking and displayed after
a glucose test, to indicate that a β-ketone
measurement is suggested (§4.2).
WRONG TEMPERATURE
ICON: appears while testing and temperature is
outside the allowed temperature range.
LOW BATTERY ICON: appears when the battery needs to be
replaced (§8.3).
NFC ICON: displayed while setting the NFC (Near
Field Communication) function (§7.6) and
when this function is enabled; blinks while
data are transmitted via NFC (§6.3.1).
CTL ICON: indicates a control solution test (§4.3).
2.2 Test strip
The following picture describes the structure of both GlucoMen® areo
Sensor and GlucoMen® areo β-Ketone Sensor.
GlucoMen® areo Sensor is white, GlucoMen® areo β-Ketone Sensor is in
light purple colour.
APPLY BLOOD/
CONTROL SOLUTION
DROP HERE
CHECK WINDOW
INSERT THIS END INTO
THE METER
3. Before testing
3.1 Caution when using the meter
Time and date are pre-set in the meter. Please make sure that time and
date settings are correct before rst use, and adjust them if needed.
Always check the settings after changing the battery (§8.3).
CAUTION
● For accurate test results, allow the meter, test strips and control
solution to adjust to the surroundings for 30 minutes before testing
your blood glucose or β-ketone levels:
Glucose test
- temperature: 5 to 45 °C (41 to 113 °F);
- humidity: 20 to 90% RH (Relative Humidity).
β-Ketone test
- temperature: 10 to 40 °C (50 to 104 °F);
- humidity: < 85% RH.
● Do not store or use the meter where:
- there are sharp temperature uctuations;
- humidity is high and causes condensation (bathrooms, drying rooms,
kitchen, etc.);
- there is a strong electromagnetic eld (close to a microwave oven,
cell phone, etc.).
● Keep the meter out of the reach of children. Coin batteries may
represent a choking hazard.
● Do not use the meter if it has been dropped in a liquid or liquids have
entered inside, even if dried afterwards.
● Avoid hand contact with test strip port on the meter. A thermo sensor
is housed inside the meter to minimize any errors.
● Do not connect the data cable to the data transfer port during testing.
The meter may be damaged, leading to inaccurate test results.
● Do not apply blood directly to the test strip port on the meter.
● Do not share your meter with anyone else to avoid the risk of infection.
●
The meter complies with applicable electromagnetic emission
requirements (EMC). However, do not perform measurements with this
meter near mobile devices or electrical or electronical equipment that
are sources of electromagnetic radiation, as these may interfere with the
proper operation of the meter.
3.2 Caution when using the test strips
CAUTION
● For testing with GlucoMen® areo 2K meter use GlucoMen® areo
Sensor or GlucoMen® areo β-Ketone Sensor only. Do not use other
test strips, it causes inaccurate test results.
● Do not use test strips after their expiry date. The expiry date is either
written on the test strip vial next to the symbol (glucose sensor) or
on the foil pouch (β-ketone sensor).
● For accurate test results, allow the meter and test strips to adjust to
the surroundings for at least 30 minutes before testing your blood
glucose or β-ketone levels:
Glucose test
- temperature: 5 to 45 °C (41 to 113 °F);
- humidity: 20 to 90% RH.
β-Ketone test
- temperature: 10 to 40 °C (50 to 104 °F);
- humidity: < 85% RH.
● After rst opening the vial, do not use the test strips beyond the time
limit indicated on the label.
● The test strips are for single-use only. Do not use test strips that have
already absorbed blood or control solution.
●Keep all unused GlucoMen® areo Sensor test strips in the original vial
and after having removed one, immediately close the cap tightly to
preserve their quality. Do not transfer them into any other container.
4. Measuring your blood glucose levels
4.1 Blood sampling
For information on how to use the lancing device, read the relevant
instructions for use.
CAUTION
● Wash the puncture site with soap and water and dry the site thoroughly
before sampling blood.
● Do not share the same lancet or lancing device with anyone else to
avoid the risk of infection.
● Always use a new lancet. Lancets are for single-use only. Do not reuse
a lancet that has already been used.
4.1.1 Alternative site testing (AST)
This meter can test the glucose levels of blood
from your ngertip, palm and forearm. However,
test results from sites other than the ngertip
may differ from ngertip measurements.
Consult your doctor or healthcare professional
before testing blood from the palm or forearm.
Use blood from: If you are going to test:
Fingertip, palm,
forearm
• Before meals.
• Two hours or more after meals.
• Two hours or more after exercise.
Fingertip • When there is the possibility of your blood glu-
cose levels changing rapidly (e.g. after meals or
exercise).
• When experiencing symptoms of hypoglycae-
mia such as perspiration, cold sweats, a oating
sensation or trembling.
• When immediate testing is needed for suspect-
ed hypoglycaemia.
• When in poor physical condition, such as with a
head cold, etc.
4.2 Testing your blood glucose
a. Insert a new GlucoMen® areo Sensor test strip (white colour) into the
test strip port. The drop icon starts blinking on the screen and the
glucose icon “Glu” will be shown at the bottom left hand corner of the
display. If nothing appears on the screen, remove the test strip, insert it
into the test strip port again and wait for the drop icon to start blinking.
b. Apply the drop of blood to the tip of the test strip until the check
window is full. A beeper sounds (if enabled) and a countdown timer
starts on the screen.
NOTE
● For accurate test results, apply the drop of blood to the tip of the test
strip within 20 seconds after puncturing.
● Do not test blood that runs or spreads out from the puncture site.
● Do not smear blood onto the test strip.
● Do not forcefully press the test strip into your puncture site.
● Do not touch the test strip once the meter has started the countdown.
c. Read your test result. You will hear a beep when the test result appears
on the screen together with the glucose icon “Glu”.

3
CAUTION
●If “LO” or “HI” appears on the screen:
Repeat the test. If “LO” or “HI” still appears, contact your doctor or
healthcare professional. “LO” appears if your test result is less than 20
mg/dL (1,1 mmol/L). “HI” appears if your test result is more than 600
mg/dL (33,3 mmol/L).
●The “hypo” or “hyper” icons may appear depending on the threshold
limit you have set (§7.4).
●β-Ketone test warning. If your own blood glucose is above a given
threshold (to be set, §7.5), the ketone icon will start blinking at the
bottom left hand corner of the display and an intermittent beep
will sound, reminding the user that a blood β-ketone test would be
recommended.
●If test results do not match with how you feel: Make sure you have
performed the test correctly as explained in §4.2. Then, conduct
a glucose control test to check that the system is working properly
(§4.3). Repeat the test using a blood sample taken from a ngertip (do
not use an alternative site). If the test result still does not match how
you feel, contact your doctor or healthcare professional.
●Do not ignore test results. Do not alter your blood glucose
management or treatment without rst consulting your doctor or
healthcare professional.
d. Press the release button to remove the test strip. The meter will
switch off.
CAUTION
● When ejecting the used test strip, point your meter downwards and
away from others.
●Disposal of biohazardous waste
Used test strips and lancets are biohazardous waste. They must therefore
be disposed according to local regulations on biohazardous waste.
4.3 Glucose control test
Conduct a control test if:
●you suspect the meter or GlucoMen® areo Sensor test strips are not
working properly;
● the meter has been dropped;
● the meter is damaged;
● your blood glucose test results do not match with how you feel;
● you want to check the performance of the meter and GlucoMen® areo
Sensor test strips when you rst get them or any time you want to check
their performance before a blood glucose test.
NOTE
●To test your meter and GlucoMen® areo Sensor test strips only use the
GlucoMen® areo Control (provided separately).
● Do not use the GlucoMen® areo Ket Control for testing the GlucoMen®
areo Sensor: erroneous results would be obtained.
CAUTION
●Do not use control solutions after their expiry date. The expiry date is
indicated on the control solution vial next to the symbol.
● For accurate test results, allow the meter, test strips and control
solution to adjust to the surroundings for at least 30 minutes before
running the control test:
- temperature: 5 to 45 °C (41 to 113 °F);
- humidity: 20 to 90% RH.
● Do not use the control solutions if 3 months or more have passed
since rst opening the vial.
●Do not drink the control solution. It is not intended for human
consumption.
● Avoid contact of the solution with the skin and the eyes as this could
cause inammation.
To perform a glucose control solution test, proceed as follows:
a. Insert a new GlucoMen® areo Sensor test strip into the test strip port.
The drop icon starts blinking on the screen and the Glucose icon
“Glu” will be shown at the bottom left hand corner of the display. If
nothing appears on the screen, remove the test strip, insert it into the
test strip port again and wait for the drop icon to start blinking.
b. Enable the CTL mode (§2.1).
WARNING
● If the CTL mode has not been enabled before performing the control
solution test, the result will be stored as a blood test and used for
calculating averages.
● Always enable the CTL mode before conducting a control solution
test or the results may fall outside the acceptable range. To enable the
CTL mode, simultaneously press the UP/DOWN ( / ) buttons for
two seconds while the drop icon is blinking on the screen.
● Once CTL mode is enabled, CTL mark is displayed together with “ctl”
message written in bigger characters on the main screen.
c. Gently shake the control solution vial before testing. Discard a drop
before use. Squeeze a drop of control solution onto a clean, hard, dry
surface.
d. Touch the control solution drop with the tip of the test strip until the
check window is full. A beeper will sound (if enabled) as the countdown
timer starts on the screen.
NOTE
● The test will not start if you apply your control solution directly to the
check window. The test starts when the meter detects the control
solution. During the test the meter counts down from 5 to 1.
●Tightly close the control solution vial.
●Do not touch the test strip once the meter has started the countdown.
e. Check that your test result is within the acceptable range indicated
on the label of the GlucoMen® areo Sensor test strip vial. If out of range,
make sure that no procedural errors were made, then repeat the control
solution test.
CAUTION
● If you still have test results that fall outside the acceptable range, stop
using the system, and contact the A. Menarini Diagnostics customer
service.
f. Press the release button to remove the test strip. The meter will
switch off.
4.4 Marking test results
After a blood (not control) glucose test is performed with a valid result, you
can mark the result as follows:
a. Start from point cof the glucose testing procedure (result displayed on
the screen, §4.2).
Press until the markers icons start blinking. Press or to scroll
through the icons (backwards or forwards) according to the following
sequence:
Before meal marker.
After meal marker.
Exercise marker.
Check marker (General Purpose marker).
Void (Once conrmed it deselects any previously selected
marker).
b. Press to conrm the marker you selected. You can select more
markers (but only one when setting or ) by repeating steps a
& b.
c. Return to point dof the glucose testing procedure (§4.2).
5. Measuring your blood β-ketone levels
5.1 Blood sampling
For information on how to use the lancing device, read the relevant
instructions for use.
CAUTION
● Wash the puncture site with soap and water and dry the site
thoroughly before sampling blood.
● Do not share the same lancet or lancing device with anyone else to
avoid the risk of infection.
● Always use a new lancet. Lancets are for single-use only. Do not reuse
a lancet that has already been used.
The GlucoMen® areo β-Ketone Sensor is not intended for alternative site
testing (AST). Use only fresh capillary whole blood from your ngertip for
testing.
5.2 Testing your blood β-ketone
a. Insert a new GlucoMen® areo β-Ketone Sensor test strip (light purple
colour) into the test strip port. The drop icon starts blinking on the
screen and the β-ketone icon “Ket” will be shown at the bottom left
hand corner of the display. If nothing appears on the screen, remove
the test strip, insert it into the test strip port again and wait for the drop
icon to start blinking.
b. Apply the drop of blood to the tip of the test strip until the check
window is full. A beeper sounds (if enabled) and a countdown timer
starts on the screen
NOTE
● For accurate test results, apply the drop of blood to the tip of the test
strip within 20 seconds after puncturing.
● Do not test blood that runs or spreads out from the puncture site.
● Do not smear blood onto the test strip.
● Do not forcefully press the test strip into your puncture site.
● Do not touch the test strip once the meter has started the countdown.
c. Read your test result. You will hear a beep when the test result appears
on the screen together with the β-ketone icon “Ket”. The test result will
blink until meter switches off.

4
CAUTION
●If “HI” appears on the screen: “HI” appears if your test result is
more than 8,0 mmol/L. Retest your blood β-ketone immediately
using a new sensor. If the reading is still high, contact your doctor
or healthcare professional immediately. “0,0” appears if your blood
β-ketone test result is less than 0,1 mmol/L: no action is required.
●If test results do not match with how you feel: Make sure you have
performed the test correctly as explained in §5.2. If no procedural
errors were made, conduct a β-ketone control test to check that the
system is working properly (§5.3). If the system is working properly
and your blood test results still do not match with how you feel,
contact your doctor or healthcare professional.
●Do not ignore test results. Do not alter your treatment on the basis
of the β-ketone result without previously consulting your doctor or
healthcare professional.
d. Press the release button to remove the test strip. The meter will
switch off.
CAUTION
● When ejecting the used test strip, point your meter downwards and
away from others.
●Disposal of biohazardous waste
Used test strips and lancets are biohazardous waste. They must therefore
be disposed according to local regulations on biohazardous waste.
5.3 β-Ketone control test
Conduct a control test if:
● you suspect the meter or GlucoMen® areo β-Ketone Sensor test strips
are not working properly;
● the meter has been dropped;
● the meter is damaged;
● your β-ketone test results do not match with how you feel;
● you want to check the performance of the meter and GlucoMen® areo
β-Ketone Sensor test strips when you rst get them or any time you want
to check their performance before a blood β-ketone test.
NOTE
● To test your meter and GlucoMen® areo β-Ketone Sensor test strips
only use the GlucoMen® areo Ket Control (provided separately).
● Do not use the GlucoMen® areo Control for testing the GlucoMen®
areo β-Ketone Sensor: erroneous results would be obtained.
CAUTION
●Do not use control solutions after their expiry date. The expiry date is
indicated on the control solution vial next to symbol.
● For accurate test results, allow the meter, test strips and control
solution to adjust to its surroundings for at least 30 minutes before
running the control test:
- temperature: 10 to 40 °C (50 to 104 °F);
- humidity: < 85% RH.
● Do not use the control solutions if 3 months or more have passed
since rst opening the vial.
●Do not drink the control solution. It is not intended for human
consumption.
● Avoid contact of the solution with the skin and the eyes as this could
cause inammation.
To perform a β-ketone control solution test, proceed as follows:
a. Insert a new GlucoMen® areo β-Ketone Sensor test strip into the test
strip port. The drop icon starts blinking on the screen and the ketone
icon “Ket” will be shown at the bottom left hand corner of the display.
If nothing appears on the screen, remove the test strip, insert it into the
test strip port again and wait for the drop icon to start blinking.
b. Enable the CTL mode (§2.1).
WARNING
● If the CTL mode has not been enabled before performing the control
solution test, the result will be stored as a blood test and used for
calculating averages.
● Always enable the CTL mode before conducting a control solution
test or the results may fall outside the acceptable range. To enable
the CTL mode, simultaneously press the UP/DOWN ( / ) buttons
for two seconds while the drop icon is blinking on the screen.
● Once CTL mode is enabled, CTL mark is displayed together with “ctl”
message written in bigger characters on the main screen.
c. Gently shake the control solution vial before testing. Discard a drop
before use. Squeeze a drop of control solution onto a clean, hard, dry
surface.
d. Touch the control solution drop with the tip of the test strip until the
check window is full. A beeper will sound (if enabled) as the countdown
timer starts on the screen.
NOTE
● The test will not start if you apply your control solution directly to the
check window. The test starts when the meter detects the control
solution. During the test the meter counts down from 8 to 1.
●Tightly close the control solution vial.
●Do not touch the test strip once the meter has started the countdown.
e. Check that your test result is within the acceptable range indicated
on the GlucoMen® areo β-Ketone Sensor test strip foil pouch. If out of
range, make sure that no procedural errors were made, then repeat the
control solution test.
CAUTION
● If you still have test results that fall outside the acceptable range, stop
using the system, and contact the A. Menarini Diagnostics customer
service.
f. Press the release button to remove the test strip. The meter will
switch off.
6. Managing your test results
WARNING
Please make sure that time and date are correct before the rst use,
and adjust them if needed (§7.1). If the time and date settings are not
correct the meter will memorize the test results assigning them wrong
time and date.
6.1 Reviewing glucose past results
You can review past results stored in the memory. Your meter stores up to
730 glucose test results with dates, times and markers.
a. Make sure the meter is off (to turn the meter off hold for 3 seconds
until the screen switches off).
b. Press for 2 seconds to turn the meter on and enter the memory recall
mode (the “mem” icon appears on the screen and the “Glu” icon will
blink).
c. Press to enter in the glucose results memory.
d. The most recent test result appears on the screen. The screen also shows
the “Glu” icon, the date and time of the test, and the corresponding
markers.
e. Press or to scroll through all the stored data.
f. Press for 5 seconds to switch the meter off.
NOTE
● If there are no results in the memory, the screen displays “ooo“.
● At the end of reviewing the individual test results, the screen displays
“ooo“.
●Keep or pressed to speed up the browsing through the results.
6.2 Viewing glucose results averages
You can view the glucose result averages over the set intervals (1, 7, 14,
30, 60 or 90 days).
a. Follow steps a, band cin §6.1.
b. Press to enter the average mode (the “AVG” icon appears on the
screen).
c. The 1-day average appears on the screen.
d. Press to scroll through the averages.
e. After reviewing the 90-day average, press to return to the memory
recall mode (step cof § 6.1).
f. Hold for 5 seconds to switch the meter off.
NOTE
● If there are less than 2 results in the memory for the
averaged period, the screen displays “ooo“. If there
are no results, the screen displays “ooo“.
● The averaging function equalises HI results to
600 mg/dL (33,3 mmol/L) and LO results to
20 mg/dL (1,1 mmol/L).
6.3 Reviewing β-ketone past results
You can review past results stored in the memory. Your meter stores up to
100 β-ketone test results with dates, times and markers.
a. Make sure the meter is off (to turn the meter off hold for 3 seconds
until the screen switches off).
b. Press for 2 seconds to turn the meter on and enter the memory recall
mode (the “mem” icon appears on the screen and the “Glu” icon will
blink).
c. Press or on time to shift to β-ketone memory section (“Ket” icon
blinking on the display).
d. Press to enter in the β-ketone results memory.
e. The most recent test result appears on the screen. The screen also shows
the “Ket” icon, the date and time of the test, and the corresponding
marker (only “ctl” is allowed for β-ketone measurement).
f. Press or to scroll through all the stored data.
g. Press for 5 seconds to switch the meter off.

5
NOTE
● If there are no results in the memory, the screen displays “ooo“.
● At the end of reviewing the individual test results, the screen displays
“ooo“.
●Keep or pressed to speed up the browsing through the results.
● To switch between β-ketone and glucose results memories during
data review, press for 3 seconds to go back to the "Glu"/"Ket"
memory mode selection.
6.4 Data transmission
Test results stored in the GlucoMen® areo 2K meter’s memory can be
also downloaded to GlucoLog® software or apps by means of either
NFC, a dedicated cable, or a Bluetooth dongle distributed by A. Menarini
Diagnostics only.
NOTE
● GlucoLog® software and apps, data cable, and Bluetooth dongles
are supplied separately. See relevant user manuals for instructions on
how to download data.
6.4.1 NFC transmission
For data transmission by means of NFC, the NFC function must be enabled
on the GlucoMen® areo 2K meter (§7.6) and an NFC equipped device
(such as a Smartphone) with GlucoLog® apps.
a. Activate the NFC transmission on the GlucoLog® app of the NFC
equipped device.
b. Bring the GlucoMen® areo 2K NFC antenna close (< 1 cm) to the
antenna of the NFC equipped device.
NOTE
● Data will be transmitted even when the meter is switched off or in
memory recall mode.
c. Data transmission will start automatically (the GlucoMen® areo 2K meter
will turn on and the blinking icon will be displayed on the screen).
d. After downloading the data, the meter switches off automatically.
WARNING
Data transmission via NFC may decrease battery life.
7. Meter setup
a. Make sure the meter is off (to turn the meter off press for 3 seconds
until the screen switches off).
b. Press for 4 seconds to enter the setup menu.
c. Press or to scroll through the setting menus (see pictures below)
and press to enter each single menu
NOTE
● At anytime during set up, you may either press to exit, or insert a test
strip to perform a test. The changes made so far will be memorized by
the meter.
7.1 Date/Time setup
Use or to select the correct value. Press to conrm and move on
to the next step: year, month, day, time format (12H, 24H), hour, minutes.
After conrming the minutes (by pressing ) return to the setting menus
(step c §7).
NOTE
● Date is in the DD-MM format.
7.2 Alarm setup
You can set up to six alarms on your GlucoMen® areo 2K meter: three for
glucose test remind, and three for β-Ketone test remind. When the alarm
reaches the set time, the meter sounds for 30 seconds.
NOTE
● Press or insert a test strip to stop the acoustic meter alarm (the
alarm will remain set).
CAUTION
● Before setting the alarms please check that the time is properly set.
a. The display will show the alarm clock and the “Glu” icons, both blinking.
Press or to scroll between glucose (“Glu” icon blinking) and
β-Ketone (“Ket” icon blinking) alarm section. Press to conrm the
selection and move on to the next step. In the following steps either
“Glu” or “Ket” icon will be shown, indicating the selected alarm section.
b. The display will show alarm 1 status (the default setting is OFF). You can
turn it on by pressing or . Press to conrm the selection and move
on to the next step.
c. Press or to select the hour. Press to conrm the selection and
move on to the next step.
d. Press or to select the minutes. Press to conrm the selection and
move on to the alarm 2 setting.
e. Set alarm 2and 3 by following steps bto d. After you have nished
setting all alarms, press to return to the setting menus (step c §7).
NOTE
● The alarm will have the format (12H, 24H) set for the time.
● Alarm settings will not be erased when changing the batteries.
7.3 Beeper setup
The beeper on your GlucoMen® areo 2K meter is preset to ON. You can
adjust the beeper feature as follows.
a. Press or to turn the beeper ON or OFF.
b. Press to conrm and return to the setting menus (step c §7).
WARNING
●Turning off the beeper could mean you miss many important cues
from your meter, such as conrmation or error messages.
7.4 hypo/hyper alarms setup
Your GlucoMen® areo 2K meter has an alarm feature that allows you to
set your high (hyperglycaemia) and low (hypoglycaemia) blood glucose
thresholds. Based on the values set, the screen will show “hypo” or “hyper”,
depending on whether your blood glucose test result is below your low
glucose or above your high glucose threshold values.
WARNING
● Consult your doctor or healthcare provider when setting the Hypo
and Hyper values.
● Do not alter or stop your medication based on this feature, always
consult your doctor or healthcare provider before altering or stopping
medication.
You can set up the hypo and hyper threshold values as follows:
a. Press or to turn the hypo alarm ON/OFF.
b. Press to set the hypo alarm value (if ON).
c. Press or to select the desired value. Press and hold either or to
accelerate the numbering.
d. Press to conrm the selection and move on to the hyper alarm setup.
e. Press or to turn the hyper alarm ON/OFF.
f. Press to set the hyper alarm value (if ON).
g. Press or to select the desired value. Press and hold either or to
accelerate the numbering.
h. Press to conrm the selection and return to the setting menus (step c
§7).
7.5 β-Ketone test warning setup
Your GlucoMen® areo 2K blood glucose and β-ketone meter has an
additional warning feature that allows you to set a blood glucose threshold
as a warning for blood β-ketone testing. When the β-ketone test warning
is turned ON, if your blood glucose is above the set threshold, the ketone
icon will start blinking and an intermittent beep will sound, reminding the
user that a blood β-ketone test would be recommended.
WARNING
● Consult your doctor or healthcare provider when setting the β-Ketone
test warning value.
● Do not alter or stop your medication based on this feature, always
consult your doctor or healthcare provider before altering or stopping
medication.
You can set up the β-ketone test warning threshold value as follows:
a. Press or to turn the β-ketone test warning ON/OFF.
b. Press to set the blood glucose threshold value (if β-ketone test
warning is ON).
c. Press or to select the desired value (rst setting: 200 mg/dL
(11,1 mmol/L)). Press and hold either or to accelerate the numbering.
d. Press to conrm the selection and return to the setting menus (step c
§7).

6
NOTE
● With high blood glucose threshold ("hyper") ON, the minimum
settable β-ketone test warning threshold is "hyper" +10 mg/dL
(+0,1 mmol/L).
7.6 NFC setup
The NFC function on your GlucoMen® areo 2K meter is preset to OFF and
can be enabled as follows:
a. Press the or buttons to select ON or OFF.
b. Press to conrm and exit.
8. Meter care
8.1 Storing your meter
After use, tightly close the caps of the test strip vial and control solution
bottle to maintain their quality.
Pack your meter, test strips, control solutions and manuals into your carry
case and store in a dry place. The correct storage temperature is -20 to
50 °C (-4 to 122 °F) for the meter and 4 to 30 °C (39,2 to 86 °F) for the test
strips and control solutions. Do not freeze. Avoid heat, humidity and direct
sunlight.
CAUTION
To obtain accurate test results:
● Do not use test strips or control solutions if their bottles or foil pouch
are broken or have been left open.
● Do not use the test strips or control solutions after their expiry dates.
8.2 Cleaning your meter
Your meter does not need special cleaning. If your meter gets dirty, wipe
it with a soft cloth moistened with mild detergent. To disinfect your meter
after cleaning, wipe with a soft cloth moistened with either 75% ethanol
alcohol or diluted household bleach (10% sodium hypochlorite solution).
8.3 Changing the batteries
When the low battery icon appears on the screen, the batteries are
getting low. Before using your meter, change the batteries.
Past results remain in the memory even when the batteries are changed.
Your meter uses two CR2032 3V lithium batteries. This type of battery is
available in many stores. Keep spare batteries handy at all times.
You do not need to set the date and time if you insert new batteries within
2 minutes after removing the old ones.
If batteries replacement takes longer than 2 minutes, the meter will
automatically require to reset Date and Time before any operation (see
§7.1).
Replace the batteries as follows:
a. Make sure the meter is switched off.
b. Remove the battery cover at the rear of the meter.
c. Remove the batteries.
d. Fit the new batteries into the battery holder with the “+” pole facing
upwards.
e. Close the battery holder.
WARNING
● If the batteries are inserted upside down, the meter will
not operate.
●The meter clock may stop if you touch the metal parts
inside the meter with your hands or metal.
● If batteries replacement takes longer than 2 minutes and
you do not reset time and date, all subsequent test results
will be stored with the incorrect date and time.
● Dispose of old batteries according to local environmental
regulations.
CAUTION
● Improper use may cause explosion or leakage of ammable liquid.
● Do not expose the batteries to extremely high temperatures.
● Do not expose the batteries to extremely low air pressure.
9. Troubleshooting
9.1 HI and LO messages
If the glucose test result is over 600 mg/dL
(33,3 mmol/L) the HI icon will appear on the display.
If the glucose test result is less than 20 mg/dL
(1,1 mmol/L) the LO icon will appear on the display.
If the β-ketone test result is over 8 mmol/L the blin-
king HI icon will appear on the display.
WARNING
● If the HI or LO message has appeared after glucose testing, please
consult your doctor or healthcare professional before altering your
treatment.
● If the HI message has appeared after β-ketone testing, please consult
your doctor or healthcare professional before altering your treatment.
● If the HI or LO results are repeatedly displayed, but your doctor judges
that they are not consistent with your conditions, please contact the
A. Menarini Diagnostics customer service.
9.2 Error messages
System Hardware Error. Remove and reinsert the
batteries to restart the meter, and repeat the test with
a new strip. If the problem persists, please contact
the A. Menarini Diagnostics customer service.
The test strip is damaged or has already been used
or the blood sample was applied before the drop
icon started to blink on the display. Remove the old
test strip and repeat the test with a new one. Wait
until the drop icon starts to blink before you begin.
Blood sample error. The blood sample did not ll
the sample area of the strip during the measurement
because the sample was not applied correctly or the
volume was insufcient. Repeat the test with a new
strip after correctly puncturing your nger (§4.1).
The strip was removed or disturbed during the
countdown. Repeat the test with a new test strip.
Low battery. Change the batteries according to the
instructions (§8.3).
The temperature was not within the recommended
range. Repeat the measurement after at least 30
minutes, when the operating temperature has been
restored.
9.3 Unexpected glucose test results
If the glucose test result is unusual compared to your previous test results
or does not match with how you feel:
a. Repeat the measurement using a new test strip (§4.2).
b. Perform a control measurement using the GlucoMen® areo Control
control solution (§4.3).
c. Change the test GlucoMen® areo Sensor strip vial and repeat the
measurement using a new test strip (§4.2).

7
d. If you are still uncertain about the test results, contact your doctor or
healthcare professional.
WARNING
● In case of an unexpected reading, consult your doctor or healthcare
professional before altering your treatment.
● If the test results continue to be unusual, please, contact the
A. Menarini Diagnostics customer service.
9.4 Unexpected β-ketone test results
If the β-ketone test result is unusual compared to your previous test results
or does not match with how you feel:
a. Repeat the measurement using a new test strip (§5.2).
b. Perform a control measurement using the GlucoMen® areo Ket Control
control solution (§5.3).
c. Repeat the measurement using a new test strip from a different foil
pouch (§5.2).
d. If you are still uncertain about the test results, contact your doctor or
healthcare professional.
WARNING
● In case of an unexpected reading, consult your doctor or healthcare
professional before altering your treatment.
● If the test results continue to be unusual, please, contact the
A. Menarini Diagnostics customer service.
10. Technical specications
General specications
Product: GlucoMen® areo 2K
Manufacturer: A. Menarini Diagnostics srl
Tested items: Blood glucose level; blood β-ketone level.
Test strip coding: No coding required.
Sample: Fresh capillary whole blood.
Temperature
compensation:
Automatic compensation using a built-in thermo
sensor.
Batteries: Two 3.0 V lithium batteries (CR2032).
Battery life: A minimum of 900 tests or about 1 year (2-3 tests/
day).
Memory: 730 glucose and 100 β-ketone test results with
markers, dates and times. When the memory is full,
the new results will replace the oldest ones.
Data management: Before/after meals, exercise, check markers
available.
Alarms: Up to six settable acoustic alarms (3 for glucose, 3
for β-ketone measurements).
Data transfer: Via dedicated USB cable or NFC (all results) or a
Bluetooth device (glucose results only).
Averages: Over 1, 7, 14, 30, 60, 90 days (for glucose results
only).
Automatic turn off: - After 90 seconds of inactivity before the test
(sensor strip inserted into the meter, drop icon
ashing).
- After 60 seconds of inactivity after the test and
Error messages Er2, Er3, Er4, HI and LO.
- After 5 seconds for Error messages Er1,
Temperature icon and Battery icon.
Dimensions: 85,5 mm (L) x 56 mm (W) x 18,2 mm (H).
Weight: 46 g (without batteries).
Meter Operating
Conditions:
- Temperature: 5 to 45 °C (41 to 113 °F) for glucose
testing; 10 to 40 °C (50 to 104 °F) for β-ketone
testing.
-
Relative Humidity: 20 to 90% (no dew condensation)
for glucose testing; < 85% for β-ketone testing.
Meter Storage
Conditions:
- Temperature: -20 to 50 °C (-4 to 122 °F).
- Relative Humidity: 20 to 90%.
Control Solutions
Storage Temperature:
4 to 30 °C (39,2 to 86 °F).
Operating
environment:
The meter complies with applicable electromag netic
emission requirements (EMC).
Operating radio
frequency band(s)
13,56 MHz
Maximum
radiofrequency
power transmitted
in the operating
frequency band(s)
0,67 nW
EU directive/
classication:
98/79/EC / Annex II, List B
Device standard: EN ISO 15197:2015
Glucose measurement specications
Unit of
measurement:
mg/dL (mmol/L)
Test range: 20 - 600 mg/dL (1,1 - 33,3 mmol/L).
Haematocrit range: 10 - 70 % (haematocrit compensated).
Test strip: GlucoMen® areo Sensor
Sample size: Minimum 0,5 μL
Test time: 5 seconds.
Assay method: Electrochemical, Glucose Oxidase (GOD,
Aspergillus niger sourced) based method.
Mediator: Hexacyanoferrate(III) ion.
Calibration and
traceability:
The results are equivalent to the plasma glucose
concentration (capillary plasma referenced). The
GlucoMen® areo 2K system is calibrated using
capillary plasma values determined with a Yellow
Springs 2300 analyser (YSI). The YSI analyser is
calibrated (as a secondary reference measurement
procedure) using a series of YSI standards (primary
calibrators) which are taken from the NIST (National
Institute of Standards and Technology, USA).
Test strip storage
conditions:
- Temperature: 4 to 30 °C (39,2 to 86 °F) (both for
unopened vial and after opening).
- Relative Humidity: 20 to 90% (both for unopened
vial and after opening).
β-Ketone measurement specications
Unit of
measurement:
mmol/L
Test range: 0,1 - 8,0 mmol/L
Haematocrit range: 20 - 60 % (haematocrit compensated).
Test strip: GlucoMen® areo β-Ketone Sensor
Sample size: Minimum 0,8 μL
Test time: 8 seconds.
Assay method: Electrochemical, β-Hydroxybutyrate
Dehydrogenase based method.
Mediator: 1,10-phenanthroline-5,6-dione.
Calibration and
traceability:
The GlucoMen® areo 2K system is calibrated using
capillary plasma values determined by means
of the Stanbio β-Hydroxybutyrate LiquiColor®
Procedure No. 2440 (Stanbio Laboratory, 1261
North Main Street, Boerne, Texas 78006). The
analyzer used to run the Stanbio kit (secondary
reference measurement procedure) is calibrated
using a series of β-hydroxybutyrate standards
(primary calibrators) prepared gravimetrically at
Stanbio Laboratory.
Test strip storage
conditions:
Temperature: 4 to 30 °C (39,2 to 86 °F).

8
48010 - 02/19
A. Menarini Diagnostics S.r.l.
Via Sette Santi, 3
50131 Firenze - Italia
XX
Distributed by:
XXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXX
XXXXXXXXXXXXXXX
XXXXXXXXXXXXXXX
XXXXXXXXXXXXXXX
XXXXXXXXXXXXXXX
Date of issue: October 2018
GlucoMen® areo 2K
Made in Taiwan
GlucoMen® areo Sensor, GlucoMen® areo β-Ketone Sensor,
GlucoMen® areo Control and GlucoMen® areo Ket Control.
See relevant instructions for use
12. Symbols and abbreviations
Consult instructions for use
Caution, consult instructions for use
Temperature limitation
Use by
Manufacturer
Batch code
In vitro diagnostic medical device
In vitro device for self-testing
Serial number
Recyclable package
CE marking
Contamination risk due to the use of blood samples
Blood glucose and β-ketone meter
Signicant additions or changes from previous user
manual revision
Direct current (voltage)
Catalogue number
The meter complies with the requirements of Directive 98/79/EC on in
vitro diagnostic medical devices and with the requirements of Directive
2011/65/EU on the restriction of use of certain hazardous substances in
electrical and electronic equipment.
The meter is in compliance with Directive 2014/53/EU on radio equipment.
The full text of the EU Declaration of Conformity is available at the following
internet address: www.red.menarinidiagnostics.com.
11. Warranty
Your GlucoMen® areo 2K meter is guaranteed to be free of material and
workmanship defects for 2 years from the date of purchase (except as
noted below). If at any time during the rst 2 years after purchase, your
GlucoMen® areo 2K meter does not work for any reason (other than as
described below), it will be replaced with a new meter, or a substantial
equivalent, free of charge.
This warranty is subject to the following exceptions and limitations:
● this warranty is only applicable to the original purchaser;
● this warranty does not apply to units which malfunction or are damaged
due to obvious tampering, misuse, alteration, neglect, unauthorized
maintenance or failure to operate meter in accordance with the
Instructions;
● there is no other express warranty for this product. The option of
replacement, described above, is the warrantor’s only obligation under
this warranty.
The original purchaser must contact A. Menarini Diagnostics: Telephone
XXXXXXXXXXXXXX.
Should you wish to extend the warranty period for your meter, please refer
to the same contact.

48010 - 02/19
GlucoMen
®
areo 2K - User Manual - MASTER
48010
02/19
210 (w) x 300 (h)
I - BLACK C